Endoscopic drop off bag

ABSTRACT

A specimen retrieval device may comprise the specimen retrieval bag for retrieval biological materials, a hybrid shaft, a first collapsible arm, and a second collapsible arm. The hybrid shaft may comprise a proximal end and a distal end, wherein the distal end is flexible, and wherein the proximal end is rigid. The first collapsible arm may be located at the distal end of the hybrid shaft, and may include a first portion. The second collapsible arm may be located at the distal end of the hybrid shaft, may include a first portion and a second portion. The second portion of the second collapsible arm may extend distally beyond the first portion of the second collapsible arm. The specimen retrieval bag may have an open end and a closed end, and may be configured to be retained upon the first collapsible arm and the second collapsible arm.

BACKGROUND

Access to the abdominal cavity may, from time to time, be required fordiagnostic and therapeutic endeavors for a variety of medical andsurgical diseases. Historically, abdominal access has required a formallaparotomy to provide adequate exposure. Such procedures, which requireincisions to be made in the abdomen, are not particularly well-suitedfor patients that may have extensive abdominal scarring from previousprocedures, those persons who are morbidly obese, those individuals withabdominal wall infection, and those patients with diminished abdominalwall integrity, such as patients with bums and skin grafting. Otherpatients simply do not want to have a scar if it can be avoided.

Minimally invasive procedures are desirable because such procedures canreduce pain and provide relatively quick recovery times as compared withconventional open medical procedures. Many minimally invasive proceduresare performed with an endoscope (including without limitationlaparoscopes). Such procedures permit a physician to position,manipulate, and view medical instruments and accessories inside thepatient through a small access opening in the patient's body.Laparoscopy is a term used to describe such an “endosurgical” approachusing an endoscope (often a rigid laparoscope). In this type ofprocedure, accessory devices are often inserted into a patient throughtrocars placed through the body wall. The trocar must pass throughseveral layers of overlapping tissue/muscle before reaching theabdominal cavity.

Still less invasive treatments include those that are performed throughinsertion of an endoscope through a natural body orifice to a treatmentregion. Examples of this approach include, but are not limited to,cholecystectomy, appendectomy, cystoscopy, hysteroscopy,esophagogastroduodenoscopy, and colonoscopy. Many of these proceduresemploy the use of a flexible endoscope during the procedure. Flexibleendoscopes often have a flexible, steerable articulating section nearthe distal end that can be controlled by the user by utilizing controlsat the proximal end. Minimally invasive therapeutic procedures to treatdiseased tissue by introducing medical instruments to a tissue treatmentregion through a natural opening of the patient are known as NaturalOrifice Translumenal Endoscopic Surgery (NOTES)™.

These minimally invasive surgical procedures have changed some of themajor open surgical procedures such as gall bladder removal, or acholecystectomy, to simple outpatient surgery. Consequently, thepatient's recovery time has changed from weeks to days. These types ofsurgeries are often used for repairing defects or for the removal ofdiseased tissue or organs from areas of the body such as the abdominalcavity.

One of the most significant problems associated with such minimallyinvasive surgical procedures is the removal of excised tissue through anopening in the body of a patient. When an infected specimen, such as aninfected gall bladder or appendix, is removed, the surgeon must beextremely careful not to spill the infected contents of the specimeninto the peritoneal cavity of the patient. A time-honored solution isthe manual cutting of the large tissue mass into small pieces that canfit through the incision. However, with this process, fragments oftissue can be dropped and fluids can be spilled into the peritonealcavity. This can be serious if the excised tissue is cancerous orinfected as this can lead to the seeding and re-spreading of cancer orthe spreading of the infection to healthy tissue.

Consequently a need exists for devices and methods that can be employedthrough a patient's natural orifice for removing biological matter in asterile manner from a body cavity.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of the invention at the time, andshould not be taken as a disavowal of claim scope.

FIGURES

The novel features of the various embodiments are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, may best be understoodby reference to the following description, taken in conjunction with theaccompanying drawings as follows.

FIG. 1 is a diagrammatical view illustrating the use of one embodimentof a surgical instrument of the present invention inserted through apatient's mouth and esophagus to perform a cholecystectomy through thestomach wall;

FIG. 2 is partial perspective view of a portion of the endoscope;

FIG. 3A illustrates one embodiment of a specimen retrieval device shownin an unfired position.

FIG. 3B illustrates one embodiment of the specimen retrieval deviceshown in a fired position.

FIG. 4A illustrates one embodiment of a proximal handle and a distalhandle of the specimen retrieval device in the unfired position.

FIG. 4B illustrates one embodiment of the distal end of the specimenretrieval device in the unfired position.

FIG. 5A illustrates one embodiment of the proximal handle and the distalhandle of the specimen retrieval device in the fired position.

FIG. 5B illustrates one embodiment of the distal end of the specimenretrieval device in the fired position.

FIG. 5C illustrates a close-up view of one embodiment of the distal endof the specimen retrieval device in the fired position.

FIG. 6 illustrates one embodiment of the proximal end of the specimenretrieval device with an outer sheath removed.

FIG. 7A illustrates one embodiment of the specimen retrieval deviceshown in an articulated position.

FIG. 7B illustrates one embodiment of a manually articulating joint.

FIG. 7C illustrates one embodiment of the manually articulating joint inan articulated position.

FIG. 8A illustrates one embodiment of the specimen retrieval device in arotated position.

FIG. 8B illustrates an exploded view of the manually articulating joint.

FIG. 9A illustrates one embodiment of a specimen retrieval bag when thespecimen retrieval device is in the fired position.

FIG. 9B illustrates a side view of one embodiment of the specimenretrieval bag.

FIG. 10 illustrates a close-up view of one embodiment of the proximalend of the proximal handle of the specimen retrieval device.

FIG. 11A illustrates one embodiment of the proximal handle and thedistal handle of the specimen retrieval device retracting thecollapsible arms.

FIG. 11B illustrates one embodiment of the distal end of the specimenretrieval device retracting the collapsible arms.

FIG. 11C illustrates a close-up view of one embodiment of the distal endof the specimen retrieval device retracting the collapsible arms.

FIG. 12A illustrates one embodiment of a knot pusher.

FIG. 12B illustrates one embodiment of the knot pusher interacting withan outer sheath of the specimen retrieval device.

FIG. 12C further illustrates one embodiment of the knot pusherinteracting with an outer sheath of the specimen retrieval device.

DESCRIPTION

Before explaining the various embodiments in detail, it should be notedthat the embodiments are not limited in their application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments maybe implemented or incorporated in other embodiments, variations andmodifications, and may be practiced or carried out in various ways. Forexample, the specimen retrieval device and the specimen retrieval bagconfigurations disclosed below are illustrative only and not meant tolimit the scope or application thereof. Furthermore, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative embodiments for theconvenience of the reader and are not to limit the scope thereof.

The various embodiments relate, in general, to specimen retrievaldevices and, more particularly, to specimen retrieval devices employingspecimen retrieval bags. The various embodiments relate, in general, tospecimen retrieval devices employing specimen retrieval bags to removebiological materials from a patient in a substantially sterile manner.Biological materials may be able to be removed in a more sterile mannerthrough the use of a specimen retrieval bag which has sufficient volumeto receive the biological material (i.e., a gall bladder, ovary,fallopian tube, appendix, etc.). A variety of different specimenretrieval devices and specimen retrieval bags are disclosed which may beuseful for both endoscopic and laparoscopic applications.

Certain embodiments will now be described to provide an overallunderstanding of the principles of the structure, function, manufacture,and use of the devices and methods disclosed herein. One or moreexamples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting embodiments and that the scope ofthe various embodiments is defined solely by the claims. The featuresillustrated or described in connection with one embodiment may becombined with the features of other embodiments. Such modifications andvariations are intended to be included within the scope of the claims.

In one general aspect, the various embodiments are directed to aspecimen retrieval device and a specimen retrieval bag, or an endoscopicdrop off bag. The specimen retrieval device may comprise the specimenretrieval bag, a hybrid shaft, a first collapsible arm, and a secondcollapsible arm. The distal end of the hybrid shaft may be flexible, andthe proximal end of the hybrid shaft may be rigid. The first collapsiblearm may be located at the distal end of the hybrid shaft, and mayinclude a first portion. The second collapsible arm may be located atthe distal end of the hybrid shaft, may include a first portion and asecond portion. The second portion of the second collapsible arm mayextend distally beyond the first portion of the second collapsible arm.The specimen retrieval bag may have an open end and a closed end, andmay be configured to be retained upon the first collapsible arm and/orthe second collapsible arm.

The specimen retrieval device may further comprise a knot pusher, anarticulating joint, an outer sheath, a distal handle, and a proximalhandle. The knot pusher may be located at the distal end of the hybridshaft. The articulating joint may connect the first collapsible arm tothe hybrid shaft and the second collapsible arm to the hybrid shaft. Theouter sheath may extend from the distal handle to the distal end of thesurgical instrument.

In another general aspect, the various embodiments are directed to amethod for using the specimen retrieval device and the specimenretrieval bag. The method may comprise inserting the specimen retrievaldevice within a patient through an opening within the patient. Once thespecimen retrieval device has been inserted, the distal handle may betranslated proximally to deploy the specimen retrieval bag and the atleast one collapsible arm from the outer sheath. Biological materialsmay then be received in the specimen retrieval bag. The distal handlemay then be translated distally to return the at least one collapsiblearm to the outer sheath. The specimen retrieval bag may then be cinchedwith the assistance of the knot pusher by pulling a suture at a proximalhandle. Finally, the specimen retrieval bag may then be removed from thepatient.

FIG. 1 is a diagrammatical view illustrating the use of one embodimentof a surgical instrument inserted through a patient's mouth andesophagus to perform a surgical activity such as to remove the patient'sgall bladder, or perform a cholecystectomy, through the stomach wall. Asillustrated in FIG. 1, in general form, a surgical instrument 20 isinserted through a natural orifice to form an opening through thestomach wall 16. The insertion may occur trans-orally (as depicted inFIG. 1), trans-anally, and/or trans-vaginally. In the example depictedin FIG. 1, the instrument 20 is inserted through the mouth 10 andesophagus 12 and into the stomach 14 to form an opening 13 through thestomach wall 16. In various embodiments, the instrument 20 may comprisea tubular member sized to receive a specimen retrieval device and or anyother suitable surgical device.

In various embodiments, for example, the tubular member may comprise aflexible endoscope 30 that may be inserted through a substantiallyhollow overtube 40 that is inserted into the stomach 14 through thepatient's mouth 10. FIG. 2 is partial perspective view of a portion ofthe flexible endoscope 30. A variety of different types of endoscopesare known and, therefore, their specific construction and operation willnot be discussed in great detail herein. In various embodiments, theflexible endoscope 30 has a distal end 32 and a proximal end 34 and mayoperably support a video camera 36 that communicates with a videodisplay unit 41 that can be viewed by the surgeon during the operation.The flexible endoscope 30 may comprise one or more working channels 38extending therethrough for receiving various types of surgicalinstruments.

In various embodiments, the flexible endoscope 30 along with a specimenretrieval device 100 (FIGS. 3A, 3B, 4A, 4B, for example) may be used inminimally invasive surgical procedures. The specimen retrieval device100 may be used in the removal of biological materials such as a gallbladder, ovaries, fallopian tubes, an appendix, or any other suitablematerial. For example, the specimen retrieval device 100 may be employedin a cholecystecomy to remove the patient's gall bladder.Cholecystecomies have traditionally been performed using laparoscopictechniques, or more invasive procedures such as an open cholecystecomy.A laparoscopic cholecystecomy requires several small incisions in theabdomen to allow the insertion of surgical instruments and a small videocamera. After the incisions are made, the surgeon will inflate theperitoneal cavity with carbon dioxide or some other similar gas. Thesurgeon watches the video output (i.e., on a monitor) and performs thegall bladder removal by manipulating the surgical instruments throughthe small incisions. An open cholecystecomy is a major abdominal surgeryin which the surgeon removes the gall bladder through an incision whichcan range from 10 to 20 centimeters. The patients recovery time after anopen cholecystecomy is quite long given the large incision in theabdominal cavity.

Newer procedures have developed which may be even less invasive than thelaparoscopic procedures used in earlier surgical procedures. Many ofthese procedures employ the use of a flexible endoscope, such as theflexible endoscope 30, during the procedure. Flexible endoscopes oftenhave a flexible, steerable articulating section near the distal end thatcan be controlled by the user by utilizing controls at the proximal end.Minimally invasive therapeutic procedures to treat diseased tissue byintroducing medical instruments to a tissue treatment region through anatural opening of the patient are known as Natural Orifice TranslumenalEndoscopic Surgery (NOTES)™. NOTES™ is a surgical technique wherebyoperations can be performed trans-orally (as depicted in FIG. 1),trans-anally, and/or trans-vaginally.

FIG. 3A illustrates one embodiment of a specimen retrieval device 100shown in an unfired position. The specimen retrieval device 100 maycomprise a proximal handle 102 and a distal handle 104. The specimenretrieval device 100 may further comprise a shaft assembly 106 and anouter sheath 108. In the unfired position, the specimen handling device100 may be inserted into one of the working channels 38 (FIG. 2) of theflexible endoscope 30 (FIGS. 1-2). In the unfired position, the distalhandle 104 is located distally from the proximal handle 102. To fire thespecimen handling device 100, the distal handle may be translatedproximally towards the proximal handle 102 in a direction A, shown byarrow 109A in FIG. 3A.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the specimen retrievaldevice 100. Thus, the specimen retrieval bag 110 (FIG. 9A) is distalwith respect to the handle assemblies of the specimen retrieval device100. It will be further appreciated that, for convenience and clarity,spatial terms such as “top” and “bottom” also are used herein withrespect to the clinician gripping the proximal handle 102. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and absolute.

FIG. 3B illustrates one embodiment of the specimen retrieval device 100shown in a fired position. In the fired position, the specimen retrievaldevice 100 deploys a collapsible arm assembly 111 which may beconfigured to retain a specimen retrieval bag 110 (illustrated in FIG.9A) for removing the biological material. In the fired position, thedistal handle 104 is located proximally to the proximal handle 102. Toreturn the specimen handling device 100 to the unfired position, thedistal handle 104 may be translated distally away from the proximalhandle in a direction B, shown by arrow 109B in FIG. 3B.

FIG. 4A illustrates one embodiment of a proximal handle 102 and a distalhandle 104 of the specimen retrieval device 100 shown in the unfiredposition. FIG. 4B illustrates one embodiment of the distal end of thespecimen retrieval device 100 shown in the unfired position. In theunfired position, the outer sheath 108 may contain at least the armassembly 111 (FIG. 3B), a manually articulating joint 116, a knot pusher118, and a specimen retrieval bag 110 (FIG. 9A). The outer sheath 108may be connected to the distal handle 104 through any suitable fasteningmeans which may include fusing, welding, gluing, bolting, rivetingand/or screwing, for example. The assembly of the outer sheath 108 andthe distal handle 104 may be configured to be received by the shaftassembly 106.

FIG. 5A illustrates the location of the proximal handle 102 relative tothe distal handle 104 of the specimen retrieval device 100 in the firedposition. FIG. 5B illustrates the distal end of the specimen retrievaldevice 100 in the fired position. The distal handle 104 may betranslated proximally towards the proximal handle, as shown by arrow109A in FIG. 5A, to expose the specimen retrieval bag 110 (FIG. 9A), thearm assembly 111, the knot pusher 118, and the manually articulatingjoint 116. A portion of the shaft assembly 106 may be exposed due to thetranslation of the distal handle 104. In various embodiments, the armassembly 111 may comprise a first collapsible arm 112 and a secondcollapsible arm 114. The first collapsible arm 112 and the secondcollapsible arm 114 may be fabricated from a resilient material such asa resilient metal, or plastic, or any other suitable resilient material.This resilient material may cause the arms 112, 114 to “spring” to anopen position once they are exposed and removed from forces created byan inner wall of the outer sheath 108. The resilient material may allowthe arms 112, 114 to return to a substantially straight “collapsed”position once they are retracted into the outer sheath 108 (see FIG.11B, for example). The exposure and retraction of the arms 112,114 maybe repeated on numerous occasions.

In various embodiments, the first collapsible arm 112 and the secondcollapsible arm 114 may extend distally along an axis L from themanually articulating joint 116. The first collapsible arm 112 and thesecond collapsible arm 114 may define an opening 113 therebetween. In atleast one embodiment, the first collapsible arm 112 may be asymmetric tothe second collapsible arm 114. In various embodiments, the firstcollapsible arm 112 may comprise an arcuate portion 180 and asubstantially straight portion 182. In the open position, the arcuateportion 180 of the first collapsible arm 112 may be defined by a radius“r₁.” In the open position, the substantially straight portion 182 maybe formed in a straight section, an elliptical section, a circularsection, or any other suitable shaped section.

In various embodiments, the second collapsible arm 114 may comprise afirst arcuate portion 181, a first substantially straight portion 183, asecond arcuate portion 184, a third arcuate portion 186, and a secondsubstantially straight portion 188. In the open position, the firstarcuate portion 181 may be defined by a radius “r₂.” In the openposition, the second arcuate portion 184 may be defined by a radius“r₃,” and the third arcuate portion 186 may be defined by a radius “r₄.”In the open position, the first substantially straight portion 183 maybe formed in a straight section, an elliptical section, a circularsection, or any other suitable shaped section. Additionally, in the openposition, the second substantially straight portion 188 may be formed ina straight section, an elliptical section, a circular section, or anyother suitable shaped section.

The arcuate portion 180 of the first collapsible arm 112 and the firstarcuate portion 181 of the second collapsible arm 114 may besymmetrical, for example, r₁ may equal r₂. Additionally, thesubstantially straight portion 182 of the first collapsible arm 112 maybe symmetrical to the first substantially straight portion 183 of thesecond collapsible arm 114. For example, the substantially straightportions 182, 183 may extend distally from the respective arcuateportions 180, 181 by a substantially identical distance. In variousother embodiments, though not illustrated, the first collapsible arm 112and the second collapsible arm 114 may be symmetrical.

FIG. 5C illustrates a close-up view of the distal end of one embodimentof the specimen retrieval device 100 in the fired position. The manuallyarticulating joint 116 may connect a flexible portion 120 of the shaftassembly 106 to the first collapsible arm 112 and the second collapsiblearm 114. The first collapsible arm 112 and the second collapsible arm114 may be fastened to the manually articulating joint 116 using anysuitable fastening means, such as, welding, fusing, gluing, screwing,bolting, riveting, or any other suitable method. The manuallyarticulating joint 116 may be fastened to the flexible portion 120 ofthe shaft assembly 106 using any suitable fastening means, such as,welding, fusing, gluing, screwing, bolting, riveting, or any othersuitable method.

In one embodiment, the first collapsible arm 112, the second collapsiblearm 114 and the knot pusher 118 extend from a distal end 122 of theshaft assembly 106. The knot pusher 118 may be contained between the armassembly 111 and the manually articulating joint 116. In at least oneembodiment, the collapsible arms 112, 114 may be formed of material thathas a rectangular cross-section (i.e., substantially flat). In otherembodiments, the collapsible arms 112, 114 may be formed of a materialwhich has a circular cross-section, a square cross-section, or any othersuitable cross-section.

FIG. 6 illustrates the proximal end of one embodiment of the specimenretrieval device 100 with the outer sheath 108 and the distal handle 104removed. A substantial amount of force may be transmitted through theshaft assembly 106 during the action of translating the distal handle104 proximally in the direction 109A (FIG. 5A) towards the proximalhandle 102 to expose the specimen retrieval bag 110. As shown in FIG. 6,the shaft assembly 106 may comprise the flexible portion 120 and a rigidportion 126. This combination of the flexible portion 120 and the rigidportion 126 may be required to overcome the substantial amount of forcewhich may be transmitted through the shaft assembly 106 as the distalhandle 104 is translated proximally.

In various embodiments, the rigid portion 126 may extend along alongitudinal axis “L” from the proximal handle to the flexible portion120. The flexible portion 120 may extend along the longitudinal axis “L”from the rigid portion 126 to the distal end 122 of the shaft assembly106. The flexible portion 120 may extend a distance which is greaterthan a distance extended by the rigid portion 126. For example, therigid portion 126 may extend approximately 25 centimeters, whereas theflexible portion 120 may extend approximately 225 centimeters. Invarious embodiments, the flexible portion 120 and the rigid portion maybe welded together or fastened using any suitable method for connectingthe flexible portion 120 to the rigid portion 126. In at least one otherembodiment, the flexible portion 120 and the rigid portion 126 may beformed of one piece of material. For example, the flexible portion 120may be machined from the rigid portion 126. In various embodiments, theflexible portion 120 may be flexible coil pipe, and the rigid portionmay be a rigid shaft. During an operation, a surgeon may be able todeform the flexible portion 120 in any direction relative to thelongitudinal axis “L” in order to assist the surgeon in placing theinstrument where it is needed. For example, referring again to FIG. 1,the surgeon may manipulate the flexible portion 120 of the shaftassembly 106 in order to remove a gall bladder using the flexibleendoscope 30. In order for the flexible portion 120 to move in a varietyof directions during an operation, the outer sheath 108 may befabricated of a flexible material to allow the flexible portion 120 tomove in accordance with the surgeon's direction.

In various embodiments, in addition to the flexible portion 120, thespecimen retrieval device 100 may comprise numerous devices forcontrolling movement of the arm assembly 111, and in particular forarticulating the specimen retrieval bag 110 relative to the shaftassembly 106. In certain embodiments, the arm assembly 111 can rotaterelative to the shaft assembly 111, and/or the shaft assembly 106 canrotate relative to the proximal handle 102. Articulation and rotation ofthe arm assembly 111 will allow the specimen retrieval bag 110 to bepositioned at various locations during a surgical procedure, therebyproviding the user with precise control over the specimen retrieval bag110. A person skilled in the art will appreciate that the specimenretrieval device 100 has application in endoscopic procedures,laparoscopic procedures, and in conventional open surgical procedures,including robotic-assisted surgery.

FIG. 7A illustrates one embodiment of the specimen retrieval device 100shown in an articulated position. The articulation may be possiblethrough the use of the manually articulating joint 116. FIG. 7Billustrates one embodiment of the manually articulating joint 116. FIG.7C illustrates one embodiment of the manually articulating joint 116 inan articulated position. Referring to FIG. 5C, the manually articulatingjoint 116 may comprise a three-bar linkage 160. The three-bar linkage160 may allow the arm assembly 111 to be oriented at an angle relativeto the longitudinal axis L. The articulation of the arm assembly 111 mayoccur about articulation joint A. The three-bar linkage 160 may includethree links 161, 162, 164 that are pivotally coupled to one another. Invarious embodiments, the three-bar linkage 160 can have a variety ofalternate embodiments. Each link in the three-bar linkage 160 can have avariety of configurations.

In at least one embodiment, the first and second links 161, 162 eachhave a generally hollow elongate shape and the third link 164 is in theform of an elongate rod or bar. The first link 161 can have a proximalend that is coupled to the distal end of the shaft assembly 106 via arotation coupling assembly (not shown). The distal end of the first link161 can be pivotally coupled to a proximal end of the second link 162,e.g., by a pivot joint. The distal end of the second link 162 can inturn be coupled to the arm assembly 111. The third link 164 can extendat least partially through the first and second links 161, 162, and itcan have a distal end that is pivotally coupled to the second link 162,e.g., by a pivot pin, to form a three-bar linkage mechanism. Theparticular location at which the third link 164 mates to the second link162 can vary. In at least one embodiment, the third link 164 mates tothe second link 162 at a location that will allow the third link 164 toapply a force to the second link 162 to cause the second link 162 toarticulate relative to the first link 161. The proximal end of the thirdlink 164 can be coupled to an articulation actuator 170 extendingthrough the shaft assembly 106 and at least partially through the firstlink 161. The articulation actuator 170 can have a variety ofconfigurations. In at least one embodiment, the articulation actuator170 may be in the form of a hollow elongate shaft or tube. Such aconfiguration may allow an actuation wire 172 to extend therethrough foractuating the arm assembly 111. The coupling 174 may be a tubular memberthat fixedly mates to the articulation actuator 170 and pivotally matesto the third link 164. A person skilled in the art will appreciate thatthe articulation actuator 170 can be directly mated to the third link164.

In various embodiments, proximal movement of the articulation actuator170 relative to the longitudinal axis L of the shaft assembly 106 mayapply a proximally-directed force to the third link 164. The third link164 may thus apply a proximally-directed force to the second link 162,and may cause the second link 162 to pivot laterally relative to thelongitudinal axis L of the shaft assembly 106. As a result, the secondlink 162, with the arm assembly 111, will move laterally in a singleplane to allow the arm assembly 111 to extend at an angle relative thelongitudinal axis L of the shaft assembly 106, as shown in FIG. 7C. Thearm assembly 111 can be returned to the original, longitudinally-alignedposition, shown in FIGS. 7A and 7B, by moving the articulation actuator170 distally relative to the shaft assembly 106.

In various embodiments, referring again to FIG. 7A, once the specimenretrieval bag 110 has been exposed, the operator of the specimenretrieval device 100 can manipulate a translation/rotation knob 128 toarticulate the arm assembly 111 or the first and second collapsible arms112, 114. This articulation may allow for easier placement of thespecimen retrieval bag 110 under the biological material to be removed.In addition, the knot pusher 118 may be articulated in this manner. Thearticulation actuator 170 may be configured to be connected to thetranslation/rotation knob 128 to allow the articulation actuator 170 tomove distally and proximally, and to rotate, in conjunction with themovement of the translation/rotation knob 128. The articulation may beachieved by translating the translation/rotation knob 128 proximallyand/or distally within the proximal handle 102, as indicated by arrow130. By translating the translation/rotation knob, the articulationactuator 170 may be translated proximally, and the arm assembly may becaused to articulate in a direction shown by the arrow 129.

FIG. 8A illustrates one embodiment of the specimen retrieval device in arotated position. FIG. 8B illustrates an exploded view of the manuallyarticulating joint 116. The rotation of the arm assembly 111 may beachieved through the use of the three-bar linkage 160. The arm assembly111 may be configured to be rotated relative to and about thelongitudinal axis L. Referring to FIGS. 7B and 7C, the three-bar linkage160 may be rotatably coupled to the distal end of the shaft assembly106, and thus the three-bar linkage 160, as well as the arm assembly111, can be positioned in various axial orientations. The rotation ofthe arm assembly 111 may occur about a rotation joint R. The location ofthe rotation joint R proximal to the articulation joint A may beparticularly advantageous in that rotation of the arm assembly 111 canchange the location of the plane within which the arm assembly 111articulates.

In various embodiments, the first link 161 can be rotatably coupled tothe distal end of the shaft assembly 106 by one or more rotationcouplings. The illustrated embodiment includes first and second rotationcouplings 166, 168. The first rotation coupling 166 may have a generallyelongate hollow shape with a proximal end that is fixedly mated to theshaft assembly 106 and a distal end having deflectable tabs 167 formedtherearound. The tabs 167 can be formed by longitudinally-extendingcut-outs formed in and spaced radially around the distal end of thefirst rotation coupling 166. Each tab 167 can include an annular flangeor lip (not shown) formed on an inner surface thereof. The secondrotation coupling 168 can have a generally elongate hollow shape, and itcan include a groove or cut-out formed therein. The first and secondrotation couplings 166, 168 can be mated by advancing the tabs 167 overthe proximal end of the second rotation coupling 168. The tabs 167 willdeflect until the annular flange or lip on the tabs 167 extends into andengages the groove 169 formed in the second rotation coupling 168. Thetwo rotation couplings 166, 168 can thus rotate relative to one another,allowing the first link 161, which is fixedly mated to the distal end ofthe second rotation coupling 168, to rotate relative to the firstrotation coupling 166 and the shaft assembly 106.

Rotation of the articulation actuator 170 can be achieved by rotatingthe articulation actuator 170. In particular, rotation of thearticulation actuator 170 relative to and about the longitudinal axis Lof the shaft assembly 106 will rotate the third link 164, which iscoupled to the second link 162, which in turn is coupled to the armassembly 111 and the first link 161. As a result, the entire three-barlinkage 160 will rotate with the arm assembly 111 relative to and aboutthe longitudinal axis L of the shaft assembly 106. Additionally,rotation can be done while the arm assembly 111 is articulated, therebychanging the plane within which the arm assembly 111 articulates.

Referring again to FIG. 8A, the operator of the specimen retrievaldevice 100 may be able to manipulate the translation/rotation knob 128to rotate the articulation actuator 170 and the arm assembly 111. Thisrotation may also allow for easier placement of the specimen retrievalbag 110 under the biological material to be removed. In addition, theknot pusher 118 may be rotated in this manner. The rotation may beachieved by rotating the translation/rotation knob 128 in the directionof rotation (either clockwise or counterclockwise) within the proximalhandle, as indicated by arrow 132. In various embodiments, thearticulation and rotation of the arm assembly 111 may occur at or nearthe same time to maneuver the specimen retrieval bag 110. Thearticulation and rotation of the arm assembly 114 may be achievedthrough the use of the articulation actuator 170. The articulationactuator 170 may be required to transmit the rotation and translationfrom the proximal handle 102 to the manually articulating joint 116. Thearticulation actuator 170 may house a suture which may run through themiddle of the articulation actuator 170.

FIG. 9A illustrates one embodiment of a specimen retrieval bag 110 whenthe specimen retrieval device 100 is in the fired position. FIG. 9Billustrates a side view of one embodiment of the specimen retrieval bag110. The specimen retrieval bag 110 may be configured to be retained onthe arm assembly 111. In various embodiments, the specimen retrieval bag110 may be rolled-up on the arm assembly 111 when the specimen retrievalbag 110 and arm assembly 111 are retained within the outer sheath 108prior to firing of the specimen retrieval device 100. The manner inwhich the specimen retrieval bag 110 is rolled may be critical due tothe operational environment of the specimen retrieval device 100. Giventhat the outer sheath 108 of the specimen retrieval device 100 may bepassed through the working channel of a flexible endoscope, the diameterof the outer sheath 108, and any item contained within the outer sheath108, may be limited. For example, the outer sheath 108 may be requiredto fit in a working channel with a diameter of about 2-5 millimeters andtypically about 3.7 millimeters.

Although the diameter of the arm assembly 111 and the rolled-up specimenretrieval bag 110 may be limited due to the dimensional limits of thediameter of the outer sheath 108, a similar limit may not exist for thelength of the arm assembly 111 and the specimen retrieval bag 110. Forexample, the length of the arm assembly 111 and the specimen retrievalbag 110 may be able to extend up to about 300 millimeters within theouter sheath 108. The relatively limited constraints on the length ofthe arm assembly 111 and the specimen retrieval bag 110 may be importantto deliver a bag of significant volume to a surgical site. In at leastone embodiment, the bag 110 may be rolled upon itself.

In the embodiment illustrated in FIG. 9B, the specimen retrieval bag 110may comprise a top end 135 and a bottom end 137. The top end 135 maycomprise an open portion 136 and a fused portion 138. The open portionmay be located near a proximal end 139, and the fused portion 138 may belocated near a distal end 140. The fused portion 138 may be formed byfusing two portions of the specimen retrieval bag 110 together. Thefused portion 138 may be formed by stitching, gluing, or using any othersuitable method for forming a fused portion 138 of the specimenretrieval bag 110. The proximal end 139 may extend distally from the topend 135 to the bottom end 137, and the distal end 140 may extenddistally from the top end 135 to the bottom end 137. The specimenretrieval bag 110 may be formed to allow the specimen retrieval bag 110to be rolled up upon itself with a reduced diameter to meet the diameterrequirements of the outer sheath 108 (FIG. 9A, for example).

With reference to FIGS. 9A and 9B, the first collapsible arm 112 may fitinto a folded portion 142 on one side of the specimen retrieval bag 110and the second collapsible arm 114 may fit into the folded portion 142on the other side of the specimen retrieval bag 110. A suture 144 mayrun through the entire folded portion 142 and may be tied in a slip knotto allow the open portion 136 to be cinched once the biological materialis put into the specimen retrieval bag 110. The asymmetric design of thearm assembly 111 enables the specimen retrieval bag 110 to receivebiological material having a higher volume compared to symmetricdesigns. The first collapsible arm 112 and the second collapsible arm114 may minimize buckling of the specimen retrieval bag 110 when the bag110 is in the rolled-up position.

FIG. 10 illustrates a close-up view of the proximal end of the proximalhandle 102 of one embodiment of the specimen retrieval device 100. Thesuture 144 may extend through an opening 146 formed in the proximal endof the proximal handle 102. The suture 144 may terminate on the exteriorof the proximal handle at an o-ring 148 or any other suitable assemblyfor retaining the suture 144. The specimen retrieval bag 110 may beremoved from the arm assembly 111 once the biological specimen has beenreceived in the specimen retrieval bag 110. First, the specimenretrieval bag 110 may be freed from the proximal handle 102 by pullingthe suture 144 loose from the proximal handle 102. The suture 144 mayextend from the folded portion 142 of the bag 110 at the distal end ofthe specimen retrieval device 100 through the center of the articulationactuator 170 and out of an opening 146 in the proximal end of theproximal handle 102.

FIG. 11A illustrates the proximal handle 102 of one embodiment of thespecimen retrieval device 100 retracting the arm assembly 111 (FIG.11B). Once the suture 144 has been freed from the proximal handle 102,the specimen retrieval bag 110 (FIGS. 9A, 9B) may be removed from thearm assembly 111. The specimen retrieval bag 110 may be removed from thearm assembly 111 by translating the distal handle 104 distally in thedirection shown by arrow 109B. As the distal handle 104 is translateddistally, the outer sheath 108 moves distally to collapse the armassembly 111 and receives the collapsed arm assembly 111 within thehollow lumen of the outer sheath 108. FIG. 11B illustrates oneembodiment of the distal end of the specimen retrieval device 100retracting the first and second collapsible arms 112, 114 within thehollow lumen defined by the outer sheath 108. FIG. 11C illustrates aclose-up view of one embodiment of the distal end of the specimenretrieval device 100 retracting the arm assembly 111. As the armassembly 111 is retracted, the knot pusher 118 may be configured to betrapped at the distal end of the outer sheath 108 and remain trapped atthe distal end of the outer sheath 108.

FIG. 12A illustrates one embodiment of a knot pusher 108. The knotpusher 118 may comprise a cylindrical portion 152 and a flared portion154. In various other embodiments, the knot pusher 118 may not belimited to a cylindrical shape such as shown by the cylindrical portion152 but may have a variety of configurations. In one embodiment, theknot pusher 118 may comprise an alternate distal portion, which may beformed in any suitable shape, such as a square or a rectangle, forexample. Prior to firing the specimen retrieving device 100, the knotpusher 118 may be completely contained within the outer sheath 108 withthe cylindrical portion 152 near the distal end of the outer sheath 108and the flared portion 154 near the distal end of the manuallyarticulating joint 116. The flared portion 154 may be held within theouter sheath 108 in a substantially non-flared position as shown in FIG.4B. This non-flared position may be attainable due to slots 156 locatedaround the periphery of the flared portion 152. These slots 156 may becut into the flared portion 152 to allow the flared portion 152 to be ina non-flared position when sufficient force is applied to the flaredportion 152 and in a flared position (as shown in FIG. 12A) when a lackof sufficient force is applied to the flared portion 152. The knotpusher 118 may be fabricated of a resilient material, such as aresilient metal, plastic, or any other suitable material, to allow theflared portion 152 of the knot pusher 118 to expand to a flared positiononce the force is removed.

FIG. 12B illustrates one embodiment of the knot pusher 118 in the flaredposition interacting with the outer sheath 108 of the specimen retrievaldevice 108. As the outer sheath 108 is being retracted, the knot pusher118 may eject from the exterior of the distal end of the outer sheath108 and expand into the flared position. In one embodiment, the suture144 may pass through the knot pusher 118 such that there may exist aknot 158 in the suture 144 at a distal end of the knot pusher 118. Thesuture 144 may enter the knot pusher 118 through an opening 160, whichmay comprise a slot, a hole, or any other suitable opening. In otherembodiments, the opening 160 may be located in the cylindrical portion152 of the knot pusher 118. The suture 144 may pass internally throughthe flared portion 152 and then exit the knot pusher 118 at the opening160. The opening 160 may be configured to allow the suture 144 to passthrough but not allow a knot 158 in the suture 144 to pass through theopening 160. The knot 158 may be formed at or near the distal end of theknot pusher 118 such that the knot 158 cannot be pulled proximallythrough the knot pusher 118.

FIG. 12C further illustrates one embodiment of the knot pusher 118interacting with the outer sheath 108 of the specimen retrieval device100. Once the specimen retrieval bag 110 has been removed from the armassembly 111, the suture 144 may be pulled proximally from the proximalhandle 102 (as shown in FIG. 10) to cinch the specimen device bag 110closed. As the loose end of the suture 144 is pulled, the knot pusher118 may rotate about an axis until the knot pusher 118 is engaged withthe outer sheath 108 to further prevent the knot pusher 118 fromentering the distal end of the outer sheath 108. In addition, the knot158 of the suture 144 is pulled tight against the knot pusher 118. Oncethe knot 158 is secured against the knot pusher 118, the suture 144 maybe pulled tight which may cinch the specimen retrieval bag 110. Once thebag 110 is cinched, elements of the specimen retrieval device 100, whichmay include the outer sheath 108, the arm assembly 111, the shaftassembly 106, and the manually articulating joint 116, may be removedfrom the working channel. This removal may occur to allow the operator,or surgeon, to place another instrument down the working channel tocomplete the surgical procedure or perform another surgical procedure.Other elements of the specimen retrieval device 100, which may includethe specimen retrieval bag 110, the suture 144, and the knot pusher 118,may be left in the patient until further procedures have taken place.The specimen retrieval bag 110 may remain at the distal end of theflexible endoscope 30 (FIGS. 1, 2) with the suture 144 tethering the bag110 to the proximal end where the operator may have control of the bag110. Upon completion of the additional procedures, the specimenretrieval bag 110 may be extubated.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the various embodiments described herein will be processedbefore surgery. First, a new or used instrument is obtained and ifnecessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK® bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility.

It is preferred that the device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

Although various embodiments have been described herein, manymodifications and variations to those embodiments may be implemented.For example, different types of specimen retrieval bags may be employed.In addition, combinations of the described embodiments may be used. Forexample, the specimen retrieval bag may comprise a fused portion at theproximal end and an open portion at the distal end. Also, wherematerials are disclosed for certain components, other materials may beused. The foregoing description and following claims are intended tocover all such modification and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

1. A surgical instrument, comprising: a hybrid shaft having a proximalend and a distal end, wherein the distal end is flexible, and whereinthe proximal end is rigid; a first collapsible arm located at the distalend of the hybrid shaft, wherein the first collapsible arm comprises afirst portion; a second collapsible arm located at the distal end of thehybrid shaft, wherein the second collapsible arm comprises a firstportion and a second portion, wherein the second portion extendsdistally beyond the first portion; and a bag having an open end and aclosed end, wherein the bag is configured to be retained upon the firstcollapsible arm and the second collapsible arm.
 2. The surgicalinstrument of claim 1, further comprising: a knot pusher located at thedistal end of the hybrid shaft; an articulating joint, wherein thearticulating joint connects the first collapsible arm to the hybridshaft and the second collapsible arm to the hybrid shaft; an outersheath extending from a distal handle to the distal end of the surgicalinstrument; and a proximal handle.
 3. The surgical instrument of claim2, wherein the hybrid shaft extends from the proximal handle to thedistal end of the surgical instrument.
 4. The surgical instrument ofclaim 2, wherein the outer sheath translates from an unfired position toa fired position upon translation of the distal handle towards theproximal handle.
 5. The surgical instrument of claim 4, wherein thehybrid shaft, the first collapsible arm, the second collapsible arm, thebag, the articulating joint, and the knot pusher are contained withinthe outer sheath in the unfired position.
 6. The surgical instrument ofclaim 4, wherein the first collapsible arm, the second collapsible arm,the bag, the articulating joint, and the knot pusher are removed fromcontainment of the outer sheath in the fired position.
 7. The surgicalinstrument of claim 6, wherein the outer sheath translates from thefired position to a retracted position upon translation of the distalhandle from the proximal handle.
 8. The surgical instrument of claim 7,wherein the first collapsible arm, the second collapsible arm, and thearticulating joint are contained within the outer sheath in theretracted position.
 9. The surgical instrument of claim 8, wherein asuture runs from the proximal handle, through the knot pusher, through atop portion of the bag, and terminates with a knot at the knot pusher.10. The surgical instrument of claim 9, wherein the suture is configuredto close the bag upon pulling the suture at the proximal handle in theretracted position.
 11. The surgical instrument of claim 9, wherein theknot pusher is configured to be retained at a distal end of the outersheath in the retracted position.
 12. The surgical instrument of claim2, wherein the first collapsible arm and the second collapsible arm maybe articulated at the articulated joint.
 13. The surgical instrument ofclaim 2, wherein the first collapsible arm and the second collapsiblearm may be rotated.
 14. A surgical instrument, comprising: a hybridshaft having a proximal end and a distal end, wherein the hybrid shaftextends from a proximal handle to the distal end of the surgicalinstrument, wherein the distal end is flexible, and wherein the proximalend is rigid; at least one collaspsible arm located at the distal end ofthe hybrid shaft; a bag having an open end and a closed end, wherein thebag is configured to be retained upon the at least one collaspsible arm;a knot pusher located at the distal end of the hybrid shaft; anarticulating joint, wherein the articulating joint connects the at leastone collapsible arm to the hybrid shaft; and an outer sheath extendingfrom a distal handle to the distal end of the surgical instrument. 15.The surgical instrument of claim 14, wherein the outer sheath translatesfrom an unfired position to a fired position upon translation of thedistal handle towards the proximal handle, wherein the hybrid shaft, theat least one collapsible arm, the bag, the articulating joint, and theknot pusher are contained within the outer sheath in the unfiredposition, and wherein the at least one collapsible arm, the bag, thearticulating joint, and the knot pusher are removed from containment ofthe outer sheath in the fired position.
 16. The surgical instrument ofclaim 15, wherein the outer sheath translates from the fired position toa retracted position upon translation of the distal handle from theproximal handle, wherein the at least one collapsible arm, and thearticulating joint are contained within the outer sheath in theretracted position.
 17. The surgical instrument of claim 16, wherein asuture runs from the proximal handle, through the knot pusher, through atop portion of the bag, and terminates with a knot at the knot pusher.18. The surgical instrument of claim 17, wherein the suture isconfigured to close the bag upon pulling the suture at the proximalhandle in the retracted position, and wherein the knot pusher isconfigured to be retained at a distal end of the outer sheath in theretracted position.
 19. A method comprising: providing a surgicalinstrument, wherein the surgical instrument may comprise a distalhandle, an outer sheath, a bag having an open end and a closed end, ahybrid shaft, and at least one collapsible arm, wherein the bag isconfigured to be retained upon the at least one collapsible arm;inserting the surgical instrument within a patient through an openingwithin the patient; translating the distal handle proximally to deploythe bag and the at least collapsible arm from the outer sheath;receiving biological materials in the bag; translating the distal handledistally to return the at least one collapsible arm to the outer sheath;cinching the bag with the assistance of a knot pusher by pulling asuture at a proximal handle; and removing the bag containing biologicalmaterial from the patient.
 20. The method of claim 19, furthercomprising: sterilizing the surgical instrument; and storing thesurgical instrument in a sterile container.